← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS I

JMT — Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)

DEVICE CLASS
Class I
REGULATION
21 CFR 862.1510
MEDICAL SPECIALTY
Clinical Chemistry
REVIEW PANEL
CH
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES

Recent clearances

K251800Healgen Scientific,, LLC · 510k2025-12-23
K252607Hangzhou AllTest Biotech Co., Ltd. · 510k2025-10-30
K242767Safecare Biotech (Hangzhou) Co., Ltd. · 510k2025-01-10

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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